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Evaluation of the Ulthera® System for Treatment of Abdominal Tissue

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01708499
First received: October 15, 2012
Last updated: February 27, 2013
Last verified: February 2013
History of Changes
  Purpose

Enrolled subjects will receive one UltherapyTM treatment on the abdomen. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.


Condition Intervention
Skin Laxity
Skin Crepiness
 Device: Ulthera System Treatment

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Ulthera® System for Efficacious and Safe Treatment of Laxity/Crepiness and Texture of Abdominal Tissue

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • Improvement laxity/crepiness and texture of abdominal tissue [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]
    Determined by a masked, qualitative assessment of photographs at 90 days post treatment compared to baseline


Secondary Outcome Measures:
  • Overall aesthetic improvement [ Time Frame: 180 days post-treatment ] [ Designated as safety issue: No ]
    The Global Aesthetic Improvement Scale scores will be obtained from the investigator and subject, comparing post-treatment photos to pre-treatment photos.


Estimated Enrollment: 20
Study Start Date: March 2012
Estimated Study Completion Date: June 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study treatment
All enrolled subjects will receive one Ulthera System Treatment.
 Device: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ultherapy™

Detailed Description:

This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System for improving laxity/crepiness and texture of abdominal tissue. Changes from baseline in the laxity, crepiness and texture of abdominal skin will be assessed at each study follow-up visit. Global Aesthetic Improvement Scale scores, assessments of dermal thickness, and patient satisfaction questionnaires will also be obtained.

  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, aged 25 to 60 years.
  • Subject in good health.
  • Skin laxity in the abdomen
  • Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
  • Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.

Exclusion Criteria:

  • Presence of an active systemic or local skin disease that may affect wound healing.
  • Severe solar elastosis.
  • Excessive subcutaneous fat in the abdomen.
  • Excessive skin laxity on the abdomen.
  • Significant scarring in areas to be treated.
  • Open wounds or lesions in the area to be treated.
  • Inability to understand the protocol or to give informed consent.
  • BMI equal to and greater than 30.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708499

Locations
United States, California
Sasaki Advanced Aesthetic Medical Center
Pasadena, California, United States, 91105
Sponsors and Collaborators
Ulthera, Inc
Investigators
Principal Investigator: Gordon Sasaki, MD
  More Information

No publications provided

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01708499     History of Changes
Other Study ID Numbers: ULT-128
Study First Received: October 15, 2012
Last Updated: February 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ulthera, Inc:
Ulthera® System
Ultherapy™ Treatment
Ulthera, Inc.
Ultrasound treatment for skin tightening

Additional relevant MeSH terms:
Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 22, 2013